Regulatory Affairs Specialist

Job Description

Regulatory Affairs Specialist
As a Regulatory Affairs Specialist, you will be a key member of our Regulatory Affairs group and required to demonstrate flexibility as priorities change.
Key role of this position is to support department goals and continuous improvement initiatives, prepare and support vigilance on regulatory data related to the company?s range of medical devices. Maintains site Regulatory Affairs compliance, based on cGMP per requirements as defined in FDA 21CFR820, ISO 13485, MDD, CMDCAS, IEC 60601, and other International Regulations.
The RA Specialist will report into the RA Manager

RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

Development of and collation of data for EU MDD Class III Design Dossiers for submission to Notified Body, maintains currency of CE Technical Files aligned with device and process changes.

Key member of the New Product Introduction, design control teams and site engineering projects to ensure device compliance to appropriate International Regulatory requirements

Experience in internal auditing for compliance to Medical Device QSRs an advantage

For further information on this Regulatory Affairs Specialist position please contact Gavin Kennedy at The RFT Group at gavin@rftgroup.ie / 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ieFollow us on Facebook, Linked-in, twitter

About

The RFT Group, are an Irish recruitment agency specialising exclusively in the recruitment of scientists, engineers and executives for the pharmaceutical, biopharmaceutical and medical device sectors across Ireland, Europe and Rest of World.